MAUDE Adverse Event Report: ALPHATEC SPINE INVICTUS SPINAL FIXATION SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 15100

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 09/08/2021

Event Type  Injury  

Manufacturer Narrative

The device has not returned to atec for evaluation.Radiographs were provided which confirmed the event.The lot number was not provided; therefore, review of the device history records could not be conducted.If additional information is received, a supplemental report will be submitted.

Event Description

A (b)(6) male underwent spinal lumbar fusion surgery on (b)(6) 2021.A revision surgery took place (b)(6) 2021 to extend the construct due to the patient having proximal junctional kyphosis (pjk).During a postop visit on (b)(6) 2021, radiographs revealed the rods were starting to pull out of iliac tulips.A 2nd revision surgery was performed on (b)(6) 2021.No patient injury reported.

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE; 1950 camino roble vida; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino roble vida; 9014283693
• MDR Report Key: 13362077
• MDR Text Key: 284505678
• Report Number: 2027467-2021-00083
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00190376137902
• UDI-Public: 00190376137902
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 15100
• Device Catalogue Number: 15100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/27/2021
• Initial Date FDA Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male